INFINITI(R) VISION SYSTEM

INFINITI(R) VISION SYSTEM is an FDA 510(k)-cleared medical device (K120912) manufactured by Alcon Manufacturing, Ltd.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 14, 2012. Regulation: 8.